Intervention Study on Iodine and Molybdenum Biofortification Vegetables ( Nutri-I-Mo )
NCT ID: NCT04984746
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-04-02
2021-07-15
Brief Summary
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Detailed Description
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The present project aims to investigate the benefits of fortified food intake in a cohort of healthy individuals. Specifically, participants will be fed with lettuce enriched with Molybdenum and lettuce enriched with Iodine in order to study any additional influence on hematological parameters of both minerals The healthy group will eat 100 gr of Lettuce with iodine and 100gr of lettuce with Molybdenum and collect plasma and urine samples after 10 days. Each subject will be subjected to two venous blood samples taken at the beginning of the observation and at the end. The samples obtained will be transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the experimenters at the laboratories of the Molecular Biology section of the University of Palermo. Serum and plasma will be obtained from each blood sample. All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study. Samples will be analyzed and compared for glucose, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin, hematocrit, hs-CRP, TSH, FT3, FT4. Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK) oxidative stress markers (LDL-ox, AGE, urinary 8-iso-prostaglandin F (PGF)2alpha) and inflammatory markers(IL-1, TNF, IL-6, IL-10)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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No Intervention: (control group)
No Intervention: (control group) The control group was assigned to lettuce without any biofortification but with the same characteristic of bioforticated lettuce(soil, water, harvesting time).
No Intervention: (control group)
Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
Experimental: intervention group
Experimental: intervention group To the intervention group was assigned the biofortificated Molibdenum lettuce and Iodine lettuce.
Experimental: intervention group
Molybdenum Iodine group
Lettuces with Iodine and Molybdenum biofortification was assigned to each participant belonging to the intervention group which ate 100gr of each type of lattuce every day for 10 days
Interventions
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No Intervention: (control group)
Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
Experimental: intervention group
Molybdenum Iodine group
Lettuces with Iodine and Molybdenum biofortification was assigned to each participant belonging to the intervention group which ate 100gr of each type of lattuce every day for 10 days
Eligibility Criteria
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Inclusion Criteria
* age: 18-65 years
* healthy status
* no drug therapy or integration therapy
Exclusion Criteria
* use of medication or suffering from any condition
* pregnancy
* breastfeeding
* current smokers
18 Years
65 Years
ALL
Yes
Sponsors
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University of Palermo
OTHER
Responsible Party
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Sara Baldassano
Associate professor
Locations
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Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
Palermo, PA, Italy
Countries
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Other Identifiers
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Nutr-I-Mo-2021
Identifier Type: -
Identifier Source: org_study_id
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